SPARK Scan

FDA 510(k) K231457 · Spark Neuro, Inc.

Substantially Equivalent

510(k) numberK231457

Submission

Device name
SPARK Scan
Applicant
Spark Neuro, Inc.
New York, NY, US
Received
May 19, 2023
Decision date
August 18, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWQ – Full-Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other 510(k)s with product code GWQ

510(k)DeviceApplicantDecision
K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)GWQ · Special Neuroelectrics Barcelona S.L.U.06/13/2026SE
K260455New Wave SystemGWQ · Special Zeto, Inc.03/13/2026SE
K233403Flexset SystemGWQ · Traditional Zeto, Inc.04/30/2024SE
K231366Neuronaute PlusGWQ · Traditional Bioserenity Sas11/09/2023SE
K221959Q21GWQ · Traditional Neurofield, Inc.08/31/2023SE
K221963Cumulus Functional Neurophysiology PlatformGWQ · Traditional Cumulus Neuroscience Limited04/27/2023SE
K230073OktiGWQ · Traditional Compumedics Limited02/09/2023SE
K223644Neuronaute with IceCap 2 & IceCap 2 SmallGWQ · Special Bioserenity01/12/2023SE
K220056iSyncWaveGWQ · Traditional iMediSync, Inc.08/10/2022SE
K212788Seer HomeGWQ · Traditional Seer Medical Pty, Ltd.06/16/2022SE

Questions and answers

When was SPARK Scan cleared by the FDA?

SPARK Scan (K231457) received a 510(k) decision of Substantially Equivalent on August 18, 2023, 91 days after the submission was received.

What is the product code of K231457?

The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.